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SPC: INTRONA Solution for injection or infusion (2020)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

IntronA 10 million IU/mL solution for injection or infusion.

Qualitative and quantitative composition

One vial of solution for injection or infusion contains 10 million IU of recombinant interferon alfa-2b produced in E. coli by recombinant DNA technology, in 1 mL of solution. For the full list of excipients, ...

Pharmaceutical form

Solution for injection or infusion. Clear and colourless solution.

Therapeutic indications

Chronic hepatitis B Treatment of adult patients with chronic hepatitis B associated with evidence of hepatitis B viral replication (presence of DNA of hepatitis B virus (HBV-DNA) and hepatitis B antigen ...

Posology and method of administration

Treatment must be initiated by a physician experienced in the management of the disease. Not all dose forms and strengths are appropriate for some indications. Appropriate dose form and strength must be ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. A history of severe pre-existing cardiac disease, e.g. uncontrolled congestive heart failure, recent myocardial ...

Special warnings and precautions for use

Psychiatric and central nervous system (CNS) Severe CNS effects, particularly depression, suicidal ideation and attempted suicide have been observed in some patients during IntronA therapy, and even after ...

Interaction with other medicinal products and other forms of interaction

Interaction studies have only been performed in adults. Narcotics, hypnotics or sedatives must be administered with caution when used concomitantly with IntronA. Interactions between IntronA and other ...

Fertility, pregnancy and lactation

Women of childbearing potential/contraception in males and females Women of childbearing potential have to use effective contraception during treatment. Decreased serum estradiol and progesterone concentrations ...

Effects on ability to drive and use machines

Patients are to be advised that they may develop fatigue, somnolence, or confusion during treatment with IntronA, and therefore it is recommended that they avoid driving or operating machinery.

Undesirable effects

See ribavirin SPC for ribavirin-related undesirable effects if IntronA is to be administered in combination with ribavirin in patients with chronic hepatitis C. In clinical trials conducted in a broad ...

Overdose

No case of overdose has been reported that has led to acute clinical manifestations. However, as for any pharmacologically active compound, symptomatic treatment with frequent monitoring of vital signs ...

Pharmacodynamic properties

Pharmacotherapeutic group: interferon alfa-2b ATC code: L03AB05 IntronA is a sterile, stable, formulation of highly purified interferon alfa-2b produced by recombinant DNA techniques. Recombinant interferon ...

Pharmacokinetic properties

The pharmacokinetics of IntronA were studied in healthy volunteers following single 5 million IU/m² and 10 million IU doses administered subcutaneously, at 5 million IU/m 2 administered intramuscularly ...

Preclinical safety data

Although interferon is generally recognised as being species specific, toxicity studies in animals were conducted. Injections of human recombinant interferon alfa-2b for up to three months have shown no ...

List of excipients

Disodium phosphate anhydrous Sodium dihydrogen phosphate monohydrate Edetate disodium Sodium chloride M-cresol Polysorbate 80 Water for injections

Incompatibilities

This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.

Shelf life

Shelf life: 18 months. Within its shelf-life, for the purpose of transport, the solution can be kept at or below 25°C for a period up to seven days before use. IntronA can be put back in the refrigerator ...

Special precautions for storage

Store in a refrigerator (2°C-8°C). Do not freeze. For storage conditions of the medicinal product, see section 6.3.

Nature and contents of container

1 mL of solution (corresponding to 10 MIU) is contained in a single dose vial (type I glass) with a stopper (halobutyl rubber) in a flip-off seal (aluminium) with a bonnet (polypropylene). IntronA is supplied ...

Special precautions for disposal and other handling

Not all dose forms and strengths are appropriate for some indications. Please make sure to select an appropriate dose form and strength. IntronA solution for injection or infusion may be injected directly ...

Marketing authorization holder

Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands

Marketing authorization number(s)

EU/1/99/127/019 EU/1/99/127/020 EU/1/99/127/021 EU/1/99/127/022

Date of first authorization / renewal of the authorization

Date of first authorisation: 9 March 2000 Date of latest renewal: 9 March 2010

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